breast cancer
Conditions
Interventions
Neratinib treatment group:NA
Sponsors
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Female patients aged >= 18 years and = 1.5×10?/L; PLT >= 90×10?/L; Hb >= 90 g/L. Biochemistry: TBIL = 55%. 12-lead ECG: QTcF (corrected by Fridericia method) < 470 ms in females (QTcF formula: QTcF = QT/(RR^1/3)). 8. For premenopausal female subjects or those who have not undergone surgical sterilization, agreement to abstain from sexual activity or use effective contraception during the study treatment and for 7 months after the last dose. 9. Voluntary participation in the study, signed informed consent, good compliance, and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Bilateral breast cancer, stage IV breast cancer, or metastatic breast cancer. 2. Inflammatory breast cancer. 3. History of any prior malignant tumor or prior receipt of antineoplastic therapy or radiotherapy for any malignant tumor, excluding cured in-situ cervical cancer, cutaneous basal cell carcinoma, or squamous cell carcinoma. 4. Concurrent participation in other clinical trials. 5. Receipt of major surgery unrelated to breast cancer within 4 weeks before randomization, or failure to fully recover from such surgery. 6. Blood transfusion or treatment with colony-stimulating factors within 2 weeks before randomization. 7. Known history of allergy to any component of the study regimen. 8. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or organ transplantation history. 9. History of any cardiac diseases, including: (1) angina pectoris; (2) clinically significant arrhythmia requiring medication; (3) myocardial infarction; (4) heart failure; (5) any other cardiac diseases determined by the investigator as unsuitable for trial participation. 10. Pregnant or lactating female patients, fertile females with positive baseline pregnancy test, or fertile females unwilling to use effective contraception throughout the trial. 11. In the investigator’s judgment, presence of concomitant diseases that seriously endanger patient safety or affect study completion (including but not limited to hypertension, severe diabetes, active infection, thyroid diseases, etc.). 12. Inability to swallow, chronic diarrhea, intestinal obstruction, or multiple factors affecting drug administration and absorption. 13. Any other conditions that, in the investigator’s opinion, make the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| invasive disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival;Distant Disease-Free Survival; | — |
Countries
China
Contacts
Public ContactCaixia Wang
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed